Official Title: “Multicenter, Open-Label (Non-Comparative) Study To Evaluate Changes In Flow Mediated Dilatation During And After A 6 Months Treatment Period With Step By Step Increased Doses With Quinapril Therapy In Post-Menopausal Women With Mild Or Moderate Hypertension”

ACE inhibitors are thought to modify the endothelium in a number of ways. Quinapril is an effective and well-tolerated ACE-I for the treatment of patients with hypertension and congestive heart failure. Quinapril produces favourable haemodynamic changes and improves ventricular and endothelial function in patients with various cardiovascular disorders. These effects are mediated through the binding of quinaprilat to both tissue and plasma-ACE.

Quinapril 10 to 40 mg once daily improved endothelial function (as measured by improved FMD or reduced vasoconstrictive/increased vasodilative response to Ach) in patients with CAD and hypertension over 2 to 6 months of therapy; improved endothelial function was also observed in patients with CHF receiving a single infusion of quinaprilat. In general, quinapril showed neutral or beneficial effects on lipid profiles, glycaemia and renal haemodynamics. (3) There are no data available considering effects of quinapril on endothelial dysfunction in post- menopausal woman with mild to moderate hypertension and with pathological endothelial function.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: quinapril
• Procedure: Laser Doppler imaging

Primary Measures

• To evaluate the effect of 10, 20 and 40 mg daily sequential quinapril doses in a 3 x 8 weeks treatment period as changes to baseline pathological FMD.

Secondary Measures

• 1.In a subgroup of about 30 patients to assess microvascular vasomotor function by laser Doppler (LD) techniques. For all patients: 2.Evaluation of changes of BP parameters. 3.Changes in PAI-1 level. 4.Collect safety data.

Inclusion Criteria:

• pathological baseline FMD (< 5%) at screening
• women in post-menopause at least for 2 years (post-menopausal defined as having amenorrhea for ł 2 years)
• mild or moderate hypertension (BP > 140/90 mmHg)

Exclusion Criteria:

• uncontrolled severe hypertension (BP > 180/110 mmHg)

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00147524

Study ID Number: A9061010

ClinicalTrials.gov Identifier: NCT00147524

Health Authority: Hungary: National Institute of Pharmacy

Link to ClinicalStudyResults.org Posting